Pulmocide’s lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

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Pulmocides lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

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Wednesday, September 15, 2021
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Program, Food, QIDP, Allergic bronchopulmonary aspergillosis, Incidence, Cystic fibrosis, US Foods, CEO, FDA, IPA, Immunodeficiency, Patient, Chronic pulmonary aspergillosis, Mortality, Chronic obstructive pulmonary disease, US FDA, United Kingdom, Review, Critical care, Asthma, Pulmonology, Special needs, Disease, Lung, US, Orphan drug, Pharmaceutical industry
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London, , GB, UK
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PULMOCIDE
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  • Pulmocides lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA
    London, UK; 15 September 2021 Pulmocide Ltd. (the Company), a late-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for patients with severe pulmonary diseases, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug, Fast Track and Qualified Infectious Disease Product designations for opelconazole (PC945) for the treatment of invasive pulmonary aspergillosis (IPA).
  • Fast Track designation is an FDA process designed to facilitate the development, and expedite the review of treatments to treat serious conditions and fill unmet medical needs.
  • Qualified Infectious Disease Product (QIDP) designation provides incentives to drug manufacturers to develop new treatments for serious fungal and antibiotic-resistant bacterial infections.
  • Pulmocides lead product is opelconazole (PC945), a novel antifungal therapy specifically designed for inhaled use to maximize the amount of drug in the lung and spare systemic exposure.



Pulmocide’s lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

Pulmocide raised $92 million in Series C funds in May 2021 to fund a registration program for opelconazole in patients with invasive pulmonary aspergillosis who have failed prior therapy

London, UK; 15 September 2021 – Pulmocide Ltd. (“the Company”), a late-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for patients with severe pulmonary diseases, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug, Fast Track and Qualified Infectious Disease Product designations for opelconazole (PC945) for the treatment of invasive pulmonary aspergillosis (IPA).

Orphan Drug designation provides companies with regulatory and financial incentives to develop and market medicines intended to treat, prevent or diagnose life-threatening or chronically debilitating rare diseases. Fast Track designation is an FDA process designed to facilitate the development, and expedite the review of treatments to treat serious conditions and fill unmet medical needs. Qualified Infectious Disease Product (QIDP) designation provides incentives to drug manufacturers to develop new treatments for serious fungal and antibiotic-resistant bacterial infections.

“The FDA’s decision to grant opelconazole Orphan Drug, Fast Track and QIDP designations acknowledges the serious unmet medical need associated with IPA and is a significant milestone in our effort to develop a treatment for IPA, a rare and debilitating disease, with less than 50% of patients responding well to first line standard of care”, commented Daniel Burgess, Chairman and CEO of Pulmocide. “We look forward to continuing to work closely with the FDA to advance this important medicine.”

About Pulmonary Aspergillosis
The incidence of pulmonary fungal disease has increased substantially over the past two decades with Aspergillus species being the most common pathogen. IPA is associated with high morbidity and mortality rates in immuno-compromised patients including those undergoing hematological stem cell or solid organ transplantation (particularly lung transplants) and some patients in critical care, including those with COVID-19-associated pulmonary aspergillosis. Aspergillus infection also plays an important role in severe asthma and cystic fibrosis and has been correlated with poorer clinical outcomes in patients with chronic obstructive pulmonary disease. Chronic lung infections with Aspergillus can leave patients with extensive and permanent lung damage, requiring a lifetime of antifungal treatment.

About Opelconazole
Pulmocide’s lead product is opelconazole (PC945), a novel antifungal therapy specifically designed for inhaled use to maximize the amount of drug in the lung and spare systemic exposure. Under a Special Needs program across several clinical centers in the United Kingdom, opelconazole was found to be well tolerated and demonstrated remarkable clinical responses. In this program, patients with a variety of different clinical profiles that had failed previous antifungal treatment options responded well when opelconazole was added to their treatment regimen. Opelconazole has the potential to be useful in a variety of conditions where Aspergillus has been implicated, including chronic pulmonary aspergillosis, cystic fibrosis, severe asthma, allergic bronchopulmonary aspergillosis, chronic pulmonary obstructive disease, severe flu, and post-COVID-19-associated lung damage. A late-stage clinical program is being initiated to support registration in patients who have failed prior therapy.

About Pulmocide
Pulmocide Ltd (www.pulmocide.com) is a late-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for patients with severe pulmonary diseases. The company is currently focused on acute and chronic treatments for pulmonary aspergillosis and its lead product is opelconazole (PC945), being developed initially for the treatment of IPA.

For further information, please contact:

Pulmocide Ltd
Jennifer Cayer
Chief Business Officer
[email protected]

Consilium Strategic Communications
Sukaina Virji, Lindsey Neville, Lucie Foster
[email protected]


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